PRECEDENTIAL

UNITED STATES COURT OF APPEALS

FOR THE THIRD CIRCUIT

_____________

Nos. 10-3046 and 10-3047

_____________

IN RE: SCHERING PLOUGH CORP.

INTRON/TEMODAR CONSUMER CLASS ACTION

Angela Montgomery, 

Appellant in No. 10-3046

International Brotherhood of Teamsters Local No. 331 

Health & Welfare Trust Fund, 

Appellant in No. 10-3047

_____________

On Appeal from the United States District Court

for the District of New Jersey

(D.C. Civil No. 2-06-cv-05774)

District Judge: Honorable Stanley R. Chesler

_____________

Argued December 15, 2011

Before: SLOVITER, VANASKIE and GREENBERG, 

Circuit Judges

(Filed: May 16, 2012)
2

Donald E. Haviland, Jr., Esq. (Argued)

Michael J. Lorusso, Esq.

Haviland Hughes

111 South Independence Mall East

The Bourse, Suite 1000

Philadelphia, PA 19106

Counsel for Plaintiff-Appellant Angela Montgomery

Stephen G. Grygiel, Esq. (Argued)

John E. Keefe, Jr., Esq.

Stephen T. Sullivan, Jr., Esq.

Keefe Bartels

170 Monmouth Street

Red Bank, NJ 07701

Counsel for Plaintiff-Appellant International 

Brotherhood of Teamsters Local No. 331 Health & 

Welfare Trust Fund

Douglas S. Eakeley, Esq.

Natalie J. Kraner, Esq.

Alan S. Modlinger, Esq.

Kristin A. Muir, Esq.

Gavin J. Rooney, Esq. (Argued)

Lowenstein Sandler

65 Livingston Avenue

Roseland, NJ 07068

Counsel for Defendant-Appellee Schering Plough 

Corp.

_____________
3

OPINION

_____________

VANASKIE, Circuit Judge.

At issue in these consolidated appeals is the standing 

of third-party payors of drugs prescribed for ―off-label‖ 

purposes, i.e., uses not approved by the Food and Drug 

Administration (―FDA‖), as well as the standing of individual 

patients prescribed drugs for off-label purposes, to pursue 

claims against a pharmaceutical company and its affiliated 

marketing entities under the Racketeer Influenced and 

Corrupt Organizations Act (―RICO‖), 18 U.S.C. § 1961, et 

seq., the New Jersey RICO statute, N.J.S.A §2C:41-1, et seq., 

as well as other state statutory and common law causes of 

action. Both groups of plaintiffs claim that the defendants 

pursued illegal marketing campaigns to persuade physicians 

to prescribe certain drugs for off-label uses. The District 

Court found that both groups of plaintiffs lacked standing 

because, inter alia, they did not allege a plausible nexus 

between the assailed marketing campaign and the physicians‘ 

decisions to prescribe certain drugs for off-label use. Having 

carefully considered the parties‘ contentions in the context of 

the entire record, we agree that dismissal of both actions for 

want of standing is warranted. Accordingly, we will affirm 

the District Court‘s well-reasoned decisions.

I.

A. The Parties

There are two sets of plaintiffs in these consolidated 

appeals. One set of Plaintiffs consists of a putative 
4

nationwide class of third-party payors (―TPPs‖).1 The other 

set of Plaintiffs is comprised of a putative nationwide class of 

individual patient-consumers who paid for prescriptions of 

certain drugs for off-label uses, with the named class 

representative being Angela F. Montgomery.2 Separate 

Amended Complaints were filed on behalf of each set of 

Plaintiffs. The Defendants common to both Amended 

Complaints are the Schering-Plough Corporation, a 

manufacturer of pharmaceutical products, and its affiliated 

marketing and sales companies, the Schering Sales 

Corporation and Schering Corporation. The TPP Amended 

Complaint also names as defendants another Schering 

subsidiary, Integrated Therapeutics Group, Inc., individual 

Schering executives Richard J. Kogan, William K. Heiden, 

and Mary Naughton, as well as unnamed individuals (―John 

Doe‖ and ―Jane Doe‖ defendants), and unknown business 

entities (―ABC Corporations‖), who purportedly participated 

in the alleged illegal and false sales and marketing 

campaigns. For sake of simplicity, we shall refer to the 

 

1

There are four TPPs named as plaintiffs: the 

International Brotherhood of Teamsters Local No. 331 Health 

& Welfare Fund (―Local 331‖), Heavy and General Laborers‘ 

Local Union 472/172 Welfare Fund, United American 

Insurance Company, and Blue Cross Blue Shield of Alabama. 

Local 331 is the only third-party payor to appeal. We are thus 

concerned only with the standing of Local 331.

2

This action originally included five named patients: 

Angela F. Montgomery, Harold Estelle, Beryl A‘Dare 

Bratton, Dorothy Bratton, and John Huston. Only Angela F. 

Montgomery has continued to pursue this matter. We are 

thus concerned only with Montgomery‘s standing.
5

Defendants collectively as ―Schering.‖ Both sets of Plaintiffs 

assert that they paid for Schering drugs that were ineffective 

or unsafe for the off-label uses for which they were 

prescribed. 

B. FDCA Labeling and Marketing Regulations

The off-label marketing claims are at least partially 

predicated on Schering‘s alleged violations of the labeling 

and marketing restrictions of the Federal Food, Drug and

Cosmetic Act, 21 U.S.C. § 301 et seq. (―FDCA‖). The FDCA 

regulates the manufacturing, marketing and sale of 

prescription drugs, and provides that a drug cannot be sold in 

interstate commerce unless it is approved by the FDA for the 

specific medical use, or ―indication,‖ listed on the drug‘s 

labeling. See 21 U.S.C. § 355(a) (―No person shall introduce 

or deliver for introduction into interstate commerce any new 

drug, unless an approval of an application filed pursuant to 

subsection (b) or (j) of this section is effective with respect to 

such drug.‖). To obtain FDA approval, drug companies 

generally must submit evidence from clinical trials and other

testing that evaluate the drug‘s risks and benefits and 

demonstrate that it is safe and effective for all of the 

indications ―prescribed, recommended, or suggested‖ on the 

drug‘s label. See id. at § 355(d).

Prescription drugs frequently have therapeutic uses 

other than their FDA-approved indications. The FDCA, 

however, generally prohibits manufacturers from marketing, 

advertising, or otherwise promoting drugs for such 

unapproved or ―off-label‖ uses. See 21 U.S.C. § 331(a) and 

(d) (prohibiting manufacturers from introducing a drug into 

interstate commerce with an intent that it be used for an off-
6

label purchase, or by ―misbranding‖ it by including 

information about unapproved uses on its label).

Because the FDCA does not regulate the practice of 

medicine, physicians may lawfully prescribe drugs for offlabel uses. See Buckman Co. v. Plaintiffs’ Legal Comm., 531 

U.S. 341, 350 (2001) (recognizing off-label usage as ―an 

accepted and necessary corollary of the FDA‘s mission to 

regulate in this area without directly interfering with the 

practice of medicine.‖); Wash. Legal Found. v. Henney, 202 

F.3d 331, 333 (D.C. Cir. 2000) (―A physician may prescribe a 

legal drug to serve any purpose that he or she deems 

appropriate, regardless of whether the drug has been approved 

for that use by the FDA.‖). Thus, there is a certain 

―asymmetry‖ in the regulation of off-label uses: while 

physicians may lawfully prescribe drugs for off-label uses, 

the FDCA generally prohibits manufacturers from marketing 

these uses to physicians. See id. at 332-33 (referring to the 

FDCA‘s ―asymmetrical—if not necessarily inconsistent—

regulatory treatment‖ of off-label uses). Indeed, the FDCA‘s 

regulatory regime prohibits manufacturers from directly 

advertising off-label uses, such as through labeling claims or 

explicit statements made by sales representatives. Moreover, 

it is also unlawful for manufacturers to engage in certain 

indirect methods of off-label marketing. For example, in 

certain circumstances it is unlawful for manufacturers to 

sponsor continuing medical education (―CME‖) courses that 

focus on off-label uses. The FDCA does, however, permit 

manufacturers to distribute information about off-label uses in 

certain limited circumstances. See id. at 333.

The drugs involved in these consolidated appeals (the 

―Subject Drugs‖) are certain oncology and Hepatitis drugs, 
7

including Intron®-A (―Intron-A‖), PEG-Intron® (―PEGIntron‖), Rebetol® (―Rebetol‖) and Rebetron® (―Rebetron‖) 

(collectively the ―Intron Franchise Drugs‖), and Temodar® 

(―Temodar‖). The FDA has approved these drugs for specific 

purposes. 

C. Criminal Case Against Schering

In June 2001, the FDA‘s Division of Drug Marketing, 

Advertising, and Communications sent Schering Sales a letter 

notifying it that the FDA had ―identified various promotional 

activities that [were] in violation of the [FDCA] and its 

implementing regulations.‖ (Information at 12-16, United 

States v. Schering Sales Corp., No. 06-CR-10250 (D. Mass. 

Aug. 29, 2006)). The letter cited a May 2001 American 

Society of Clinical Oncology Annual Meeting in San 

Francisco at which the FDA witnessed Schering sales 

representatives give purportedly ―false or misleading efficacy 

information about Temodar to visitors at the commercial 

exhibit hall booth,‖ and ―promote[] Temodar for the 

unapproved use in first line therapy of anaplastic 

astrocytoma.‖ (Id. at 12-13). The FDA‘s letter requested that 

Schering ―immediately cease making such violative 

statements and any other promotional activities or materials 

for Temodar that make the same or similar claims or 

presentations.‖ (Id. at 13). 

In August 2006, the United States Attorney for the 

District of Massachusetts charged Schering Sales with 

conspiracy to make false statements to the federal 

government, in violation of 18 U.S.C. § 371. (Id. at 12-16). 

The Government‘s one-count Information alleged that 

―Schering Sales and its co-conspirators knowingly and 

willfully made material false statements to the FDA.‖ (Id. at 
8

8). It stated that Schering Sales‘ response to the FDA June 

2001 letter specifically asserted that Schering‘s home office 

had ―aggressively pursued sales of Intron A and Temodar for 

unapproved uses‖ through numerous methods, including 

training the sales force to seek off-label sales, requiring the 

sales force to ―create business plans that emphasized detailed 

promotional goals to obtain off-label sales,‖ and 

compensating the sales force partly on their success in 

achieving off-label sales. (Id.)

Schering Sales pleaded guilty to the one-count 

Information pursuant to a written Settlement Agreement. 

(See Amended Judgment, United States v. Schering Sales 

Corp., 06-CR-10250 (D. Mass. Feb 7, 2007)). Under the 

Settlement Agreement, Schering Sales agreed to pay fine of 

$180 million. (Id.) It also agreed to pay $255 million to 

resolve civil claims that it defrauded U.S. Government health 

benefit programs, including Medicare, Medicaid, and the 

Veteran‘s Administration. (Id.)

D. Consolidated Putative Class Action

Following Schering‘s settlement with the Government, 

various civil suits were filed across the country by consumer 

plaintiffs who were prescribed, consumed, and paid for the 

drugs, and by TPPs who paid for the Subject Drugs 

prescribed to their plan members. The Judicial Panel on 

Multi-District Litigation ordered the cases to be transferred to 

the District of New Jersey, where Schering is incorporated, 

and consolidated pursuant to 28 U.S.C. § 1407.

The District Court directed that the various actions 

transferred to it be consolidated for pretrial management and 

that a consolidated complaint on behalf of all plaintiffs be 
9

filed. In December 2007, the nine named plaintiffs (the four 

TPPs and five patients identified in footnotes 1 and 2, supra) 

filed a Consolidated Class Action Complaint (the 

―Complaint‖) on behalf of themselves and others similarly 

situated, alleging that the Defendants engaged in illegal 

promotion of the Subject Drugs in violation of the federal and 

New Jersey RICO statutes (Counts I and II), and the New 

Jersey Consumer Fraud Act (―NJCFA‖), N.J. Stat. Ann. § 

56:8-1, et seq. (Count III). The Complaint also asserted 

common law claims for unjust enrichment (Count IV); civil 

conspiracy (Count V); fraud (Count VI); negligent 

misrepresentation (Count VII); aiding and abetting breach of 

fiduciary duty (Count VIII); and equitable accounting (Count 

IX). 

In an Order and Opinion issued on July 10, 2009, the 

District Court dismissed the Complaint in its entirety pursuant

to Fed. R. Civ. P. 9(b), 12(b)(1) and 12(b)(6), for failure to 

state a claim and lack of standing, but granted leave to file an 

amended complaint. In re Schering-Plough Corp. 

Intron/Temodar Consumer Class Action, Slip Copy, 2009 WL 

2043604 (D.N.J. 2009) (―Schering I‖). The Court found that 

the Complaint lacked sufficient factual allegations to 

plausibly assert an injury-in-fact that was cognizable under 

any of the asserted causes of action and fairly traceable to the 

Defendants‘ alleged misconduct. 

In September 2009, two separate Amended Complaints 

were filed, one by Montgomery and the other by the four TPP 

plaintiffs identified in footnote 1, supra. Montgomery filed 

an Amended Civil Consumer Class Action Complaint 

(―MAC‖) individually and on behalf of a putative nationwide 

class of similarly situated patient-consumers who purchased, 
10

were reimbursed, and/or paid for any of the Subject Drugs 

during the class period. The MAC asserted violations of the 

Washington State Consumer Protection Act, Wash. Rev. 

Code § 19.86.010, et seq. (Count I), and the consumer 

protection statutes of the remaining 49 states, the District of 

Columbia, and Puerto Rico (Count II), as well as claims of 

civil conspiracy (Count III), aiding and abetting breach of 

fiduciary duty (Count IV), and unjust enrichment (Count V). 

The TPP plaintiffs filed an Amended Consolidated 

Class Action Complaint (―TPP Complaint‖) on behalf of a 

proposed class of health and welfare funds and other TPPs 

who paid any portion of the purchase price for the Subject 

Drugs during the class period. The TPP Complaint asserted 

violations of the federal and New Jersey RICO statutes, 

(Counts I and II), in addition to common law claims for 

intentional interference with contractual relations (Count III) 

and unjust enrichment (Count IV).

The Plaintiffs‘ Amended Complaints allege that 

Schering engaged in a widespread marketing campaign that 

employed illegal techniques to promote prescriptions of the 

Subject Drugs for off-label uses. They contend that these 

illegal practices included: (1) promoting certain of the Subject 

Drugs for off-label uses; (2) using false and misleading 

statements to promote certain of the Subject Drugs as 

effective, safe, and cost-effective for off-label uses; and (3) 

providing physicians with disguised and undisguised bribes, 

kickbacks and other illegal inducements to encourage them to 

prescribe the Subject Drugs for off-label uses.

Plaintiffs claim that Schering used a variety of 

methods to effectuate this marketing scheme and disseminate 

its false claims. For example, they allege that Schering 
11

trained its sales representatives to mislead medical 

professionals about the Subject Drugs‘ effectiveness for offlabel uses by distorting contrary scientific data and the results 

of clinical studies. They also claim that the Schering sales 

force promoted off-label prescriptions by disseminating false 

and misleading statements in private sales meetings with 

doctors, at medical conferences, and in CME programs. 

Plaintiffs also assert that Schering promoted these off-label 

prescriptions through both disguised and undisguised bribes 

to induce doctors to prescribe the Subject Drugs.

Plaintiffs aver that Schering‘s unlawful marketing 

practices caused physicians to prescribe the Subject Drugs for 

off-label uses instead of equally effective alternative 

treatments that were approved for the prescribed uses or no 

medication at all. They assert that these marketing techniques 

led to a significant increase in prescriptions of the Subject 

Drugs for off-label uses, and contend that this caused the 

Plaintiffs ―ascertainable loss‖ because they paid ―hundreds of 

millions, if not billions, of dollars for the Subject Drugs that 

they otherwise would not have paid.‖ 

On October 28, 2009, Schering filed separate motions 

to dismiss each Amended Complaint. On June 9, 2010, the 

District Court issued separate Orders and Opinions 

(collectively, ―Schering II‖) granting both motions. The 

Court dismissed the TPP Complaint because it failed to 

adequately plead the injury-in-fact and causation elements 

required to establish standing to assert its RICO, interference 

with contractual relations, and unjust enrichment claims. The 

Court also held that even if the Complaint had established 

standing to pursue non-RICO claims, its two common law 

claims of interference with contractual relations and unjust 
12

enrichment would still fail under Rule 12(b)(6). The Court 

dismissed the MAC for failure to show a causal link between 

Montgomery‘s alleged injury and Schering‘s alleged

misconduct. 

II. 

We have jurisdiction over this appeal pursuant to 28 

U.S.C. § 1291. We exercise plenary review over the District 

Court‘s dismissal of the Amended Complaints. See United 

States ex rel. Atkinson v. Pa. Shipbuilding Co., 473 F.3d 506, 

514 (3d Cir. 2007) (review of dismissal for lack of subject 

matter jurisdiction under Rule 12(b)(1) is plenary); Howard 

Hess Dental Labs. Inc. v. Dentsply Int’l, Inc., 602 F.3d 237, 

246 (3d Cir. 2010) (review of Rule 12(b)(6) dismissal is 

plenary).

Under Fed. R. Civ. P. 12(b)(1), a court must grant a 

motion to dismiss if it lacks subject-matter jurisdiction to hear 

a claim. ―A motion to dismiss for want of standing is . . . 

properly brought pursuant to Rule 12(b)(1), because standing 

is a jurisdictional matter.‖ Ballentine v. United States, 486 

F.3d 806, 810 (3d Cir. 2007). In evaluating a Rule 12(b)(1) 

motion, a court must first determine whether the movant 

presents a facial or factual attack. Mortensen v. First Fed. 

Sav. & Loan Ass’n, 549 F.2d 884, 891 (3d Cir. 1977). In 

reviewing a facial challenge, which contests the sufficiency of 

the pleadings, ―the court must only consider the allegations of 

the complaint and documents referenced therein and attached 

thereto, in the light most favorable to the plaintiff.‖ Gould 

Elec. Inc. v. United States, 220 F.3d 169, 176 (3d Cir. 2000). 

The Defendants‘ Rule 12(b)(1) motions are properly 

understood as facial attacks because they contend that the 
13

Amended Complaints lack sufficient factual allegations to 

establish standing.

In evaluating whether a complaint adequately pleads 

the elements of standing, courts apply the standard of 

reviewing a complaint pursuant to a Rule 12(b)(6) motion to 

dismiss for failure to state a claim: ―Court[s] must accept as 

true all material allegations set forth in the complaint, and 

must construe those facts in favor of the nonmoving party.‖ 

Ballentine, 486 F.3d at 810 (citing Warth v. Seldin, 422 U.S. 

490, 501 (1975)); see also Baldwin v. Univ. of Pittsburgh 

Med. Ctr., 636 F.3d 69, 73 (3d Cir. 2011) (―A dismissal for 

lack of statutory standing is effectively the same as a 

dismissal for failure to state a claim.‖). The Supreme Court 

most recently explained this standard in Bell Atl. Corp v. 

Twombly, 550 U.S. 544 (2007), and Ashcroft v. Iqbal, 129 

S.Ct. 1937 (2009): ―[A] complaint must contain sufficient 

factual matter, accepted as true, to  ̳state a claim to relief that 

is plausible on its face.‘‖ Iqbal, 129 S.Ct. at 1949 (quoting

Twombly, 550 U.S. at 570). We have outlined a three-step 

approach to evaluating whether a complaint satisfies this 

standard:

First, the court must ―tak[e] note of the 

elements a plaintiff must plead to state a claim.‖ 

Second, the court should identify allegations 

that, ―because they are no more than 

conclusions, are not entitled to the assumption

of truth.‖ Finally, ―where there are wellpleaded factual allegations, a court should 

assume their veracity and then determine 

whether they plausibly give rise to an 

entitlement for relief.‖
14

Santiago v. Warminster Twp., 629 F.3d 121, 130 (3d Cir. 

2010) (quoting Iqbal, 129 S.Ct. at 1947-50) (footnote 

omitted).

While the plausibility standard does not impose a 

―probability requirement,‖ it does demand ―more than a sheer 

possibility that a defendant has acted unlawfully.‖ Iqbal, 129 

S.Ct. at 1949 (citing Twombly, 550 U.S. at 556). Pursuant to 

Iqbal‘s clarification of the plausibility determination as a 

―context-specific task that requires the reviewing court to 

draw on its judicial experience and common sense,‖ id., this 

Court has found that ―[s]ome claims require more factual 

explication than others to state a plausible claim for relief.‖ 

West Penn Allegheny Health Sys., Inc. v. UPMC, 627 F.3d 85, 

98 (3d Cir. 2010). We have reasoned that, ―[f]or example, it 

generally takes fewer factual allegations to state a claim for 

simple battery than to state a claim for antitrust conspiracy.‖ 

Id.

―A complaint has to  ̳show‘ such an entitlement with 

its facts.‖ Fowler v. UPMC Shadyside, 578 F.3d 203, 211 (3d 

Cir. 2009). With respect to 12(b)(1) motions in particular, 

―[t]he plaintiff must assert facts that affirmatively and 

plausibly suggest that the pleader has the right he claims 

(here, the right to jurisdiction), rather than facts that are 

merely consistent with such a right.‖ Stalley v. Catholic 

Health Initiatives, 509 F.3d 517, 521 (8th Cir. 2007).

III.

Article III of the Constitution limits the scope of the 

Federal judicial power to the adjudication of ―cases‖ or 

―controversies.‖ U.S. Const. art. III, § 2. This ―bedrock 

requirement,‖ Valley Forge Christian Coll. v. Ams. United for 
15

Separation of Church & State, Inc., 454 U.S. 464, 471 (1982), 

protects the system of separated powers and respect for the 

coequal branches by restricting the province of the judiciary 

to ―decid[ing] on the rights of individuals.‖ Marbury v. 

Madison, 5 U.S. (1 Cranch) 137, 170 (1803). Indeed, ― ̳[n]o 

principle is more fundamental to the judiciary‘s proper role in 

our system of government than the constitutional limitation of 

federal-court jurisdiction to actual cases or controversies.‘‖ 

Raines v. Byrd, 521 U.S. 811, 818 (1997) (quoting Simon v. 

E. Ky. Welfare Rights Org., 426 U.S. 26, 37 (1976)).

The courts have developed several justicability 

doctrines to enforce the case-or-controversy requirement, and 

―perhaps the most important of these doctrines‖ is the 

requirement that ―a litigant have  ̳standing‘ to invoke the 

power of a federal court.‖ Allen v. Wright, 486 U.S. 737, 750 

(1984). ―[T]he standing question is whether the plaintiff has 

 ̳alleged such a personal stake in the outcome of the 

controversy‘ as to warrant his invocation of federal-court 

jurisdiction and to justify exercise of the court's remedial 

powers on his behalf.‖ Warth, 422 U.S. at 498-99 (citing

Baker v. Carr, 369 U.S. 186, 204 (1962)).

The plaintiff bears the burden of meeting the 

―irreducible constitutional minimum‖ of Article III standing 

by establishing three elements:

First, the plaintiff must have suffered an injury 

in fact—an invasion of a legally protected 

interest which is (a) concrete and particularized 

and (b) actual or imminent, not conjectural or 

hypothetical. Second, there must be a causal 

connection between the injury and the conduct 

complained of—the injury has to be fairly 
16

traceable to the challenged action of the 

defendant, and not the result of the independent 

action of some third party not before the court. 

Third, it must be likely, as opposed to merely 

speculative, that the injury will be redressed by 

a favorable decision.

Lujan v. Defenders of Wildlife, 504 U.S. 555, 560-61 (1992) 

(internal quotations, alterations, and citations omitted). 

We have recognized that of the three required elements 

of constitutional standing, ―the injury-in-fact element is often 

determinative.‖ Toll Bros., Inc. v. Twp. of Readington, 555 

F.3d 131, 138 (3d Cir. 2009). To satisfy this requirement, the 

alleged injury must be ―particularized,‖ in that it ―must affect 

the plaintiff in a personal and individual way.‖ Lujan, 504 

U.S. at 560 n.1. ―[T]he  ̳injury in fact‘ test requires more than 

an injury to a cognizable interest. It requires that the party 

seeking review be himself among the injured.‖ Id. at 563

(quoting Sierra Club v. Morton, 405 U.S. 727, 734-35 

(1972)). The injury must also be ―an invasion of a legally 

protected interest.‖ Id. at 560. Since ―standing is not 

dispensed in gross,‖ Lewis v. Casey, 518 U.S. 343, 358 n.6 

(1996), a plaintiff who raises multiple causes of action ―must 

demonstrate standing for each claim he seeks to press.‖ 

DaimlerChrysler Corp. v. Cuno, 547 U.S. 332, 352 (2006). 

Furthermore, ―the standing inquiry requires careful judicial 

examination of a complaint's allegations to ascertain whether 

the particular plaintiff is entitled to an adjudication of the 

particular claims asserted.‖ Allen, 468 U.S. at 752.

A. Local 331
17

The District Court dismissed the TPP Complaint in its 

entirety for lack of standing and failure to state a claim. 

Local 331 contends that the Court applied the wrong standard 

of review and consequently erred in finding that the TPP 

Complaint fails to adequately plead facts to establish an 

injury-in-fact that is fairly traceable to the Defendants‘ 

alleged misconduct. Local 331 also argues that the Court 

erred in finding that it failed to state a claim for tortious 

interference with contract and unjust enrichment. We address 

each of these arguments in turn.

Counts I and II of the TPP Complaint assert causes of 

action under the federal and New Jersey RICO statutes, 

respectively. The federal RICO statute creates a civil remedy, 

including an award of treble damages, costs, and attorneys 

fees, for ―any person injured in his business or property‖ by a 

violation of one of RICO‘s substantive provisions. 18 U.S.C. 

§1964(c). Pursuant to 18 U.S.C. § 1962(c), it is unlawful for 

― ̳any person‘ who is employed by or associated with  ̳any 

enterprise‘ affecting interstate commerce to  ̳participate, 

directly or indirectly, in the conduct of such enterprise‘s 

affairs through a pattern of racketeering activity.‘‖ Genty v. 

Resolution Trust Corp., 937 F.2d 899, 906 (3d Cir. 1991)

(quoting 18 U.S.C. § 1962(c)). The RICO statute defines 

racketeering activity by a list of crimes, or ―predicate 

offenses,‖ including several state felonies such as murder, 

kidnapping, and bribery that are punishable by imprisonment 

for more than one year, and federal crimes such as bribery, 

mail fraud and wire fraud. 18 U.S.C. § 1961(1).

The TPP Complaint also alleges violations of the New 

Jersey RICO statute, N.J. Stat. Ann. § 2C:41-4(c), based on 

the same alleged enterprises, predicate offenses, and pattern 
18

of racketeering activity as those alleged in support of the 

federal RICO claims. (TPP Compl. ¶¶396-403.) Since the 

TPP Complaint‘s federal and New Jersey RICO claims 

parallel each other, and because the two RICO statutes are 

intended to be coextensive, we follow the District Court‘s 

approach and analyze the two claims concurrently. (See A. 

86, n.3); see also Cetel v. Kirwan Fin. Grp., Inc., 460 F.3d 

494, 510 (3d Cir. 2006) (―[T]he New Jersey Supreme Court 

believed the New Jersey RICO statute was and should be 

consistent with the federal RICO statute.‖) (citing State v. 

Ball, 661 A.2d 251 (N.J. 1995)).

In addition to meeting the constitutional standing 

requirements, ―plaintiffs seeking recovery under RICO must 

satisfy additional standing criterion set forth in section 

1964(c) of the statute.‖ Maio v. Aetna, Inc., 221 F.3d 472, 

482 (3d Cir. 2000). Section 1964(c) confers standing upon 

―any person injured in his business or property by reason of a 

violation of section 1962 of this chapter . . .‖ 18 U.S.C. § 

1964(c). We have interpreted this language as requiring 

RICO plaintiffs to ―make two related but analytically distinct 

threshold showings‖ to establish standing: ―(1) that the 

plaintiff suffered an injury to business or property; and (2) 

that the plaintiff‘s injury was proximately caused by the 

defendant‘s violation of 18 U.S.C. § 1962.‖ Maio, 221 F.3d 

at 483. 

The District Court in this case conducted an extensive 

analysis of the TPP Complaint to determine if it complied 

with the RICO standing requirement of alleging injury to 

business or property. It concluded that the TPP Complaint 

did not allege a concrete injury to TPP business or property 

because it did not contain sufficient allegations that they paid 
19

for prescriptions of the drugs that were actually ineffective or 

otherwise worth less than what they paid for them. On 

appeal, the parties focused their arguments, in significant part, 

on debating this conclusion. 

Although we agree with the District Court‘s 

conclusion in this respect, we need not reach the question of 

standing under RICO. It is well-established that a plaintiff‘s

Article III standing is a prerequisite for the federal courts to 

decide the merits of a suit. See Steel Co. v. Citizens for a 

Better Environment, 523 U.S. 83, 109-10 (1998). Therefore, 

prior to considering whether Local 331 has standing to bring 

a RICO claim, we must determine whether it has Article III 

standing to invoke the jurisdiction of this Court. Because we 

find that Local 331 has not established that its alleged injury 

is fairly traceable to Schering‘s alleged wrongful conduct, we 

conclude that the Complaint was properly dismissed for lack 

of Article III standing. 

The District Court held that the TPP Complaint fails to 

sufficiently allege facts to establish that the plaintiffs‘ offlabel purchases of the Subject Drugs—―assuming one were to 

constitute injury-in-fact‖—is fairly traceable to Schering‘s 

allegedly unlawful marketing practices, and ―specifically to 

misrepresentations about the [drugs] and/or to conduct 

characterized as bribery.‖ (A. 95.) On appeal, Local 331 

argues that if the Court had ―properly applied [the causation] 

standard to the plausibility test, it would have determined that 

there is a traceable connection from Local 331‘s injuries to 

the Defendant‘s illegal marketing scheme.‖ (Local 331 Br. at 

18.)
20

We limit our analysis to the injury and causation 

theories that Local 331 raises on appeal.3 In the Statement of 

Case section of its Brief, Local 331 mentions three distinct 

injuries. First, it paid for off label prescriptions that were 

ineffective. Second, it paid for off label prescriptions when 

less expensive but equally effective medication was available. 

And third, it ―paid for elevated drug prices that recouped the 

costs of Schering‘s illegal marketing.‖ (Local 331 Br. At 4.) 

The argument section of its Brief, however, is limited to 

economic loss based on paying for ineffective drugs. 

Accordingly, we further limit our analysis to the question of 

whether the TPP complaint alleges a causal link between the 

challenged conduct and the injury that Local 331 actually 

argues on appeal.

On appeal, Local 331 defends its standing to sue in 

large part on the basis of drug purchases made by the other 

TPP Plaintiffs. It cites allegations that the Defendants made 

false claims about Temodar and Intron-A, and the other TPP 

Plaintiffs‘ purchases of those drugs for off-label indications. 

(Local 331 Br. at 14-17.) Such allegations are unhelpful to 

Local 331, which does not allege that it ever paid for a 

Temodar or Intron-A prescription. See Lewis v. Casey, 518 

U.S. 343, 347 (1996) (requiring named plaintiffs in a putative 

class action to allege ―that they personally have been injured, 

not that injury has been suffered by other, unidentified 

members of the class . . . .‖). Accordingly, we will assess 

whether the TPP Complaint contains sufficient factual 

 

3 We, of course, have no jurisdiction to decide the 

standing of those TPP Plaintiffs who have not appealed. See 

Torres v. Oakland Scavenger Co., 487 U.S. 312, 317 (1988); 

Nocula v. UGS Corp., 520 F.3d 719, 725 (7th Cir. 2008). 
21

allegations to confer standing upon Local 331 based upon its 

alleged purchases. 

According to the TPP Complaint, Local 331‘s 

damages are limited to two prescriptions of Rebetol: 

Member Kraft and Member Maurone were both 

prescribed Rebetol during the Class Period 

which were paid for in large part by Local 331. 

Upon information and belief, these prescriptions 

were written for off-label uses by physicians 

improperly influenced by the false and 

misleading statements, bribes, and other 

dishonest inducements brought to bear by 

Defendants‘ illegal off-label marketing scheme.

(TPP Compl. ¶21.)4 Accordingly, to establish standing, Local 

331 must allege facts showing a causal relationship between 

the alleged injury—payments for Rebetol that was ineffective 

or unsafe for the use for which it was prescribed—and 

Schering‘s alleged wrongful conduct.

To show the requisite causal connection, Local 331 

must allege sufficient facts to plausibly support ―a causal 

connection between the injury and the conduct complained 

 

4

Local 331 claims that the TPP Complaint ―alleged 

with requisite specificity that [Local 331] paid for Intron 

Franchise Drugs like Rebetol.‖ (Local 331 Reply at 9) 

(emphasis added). However, Local 331 does not cite any 

portion of the TPP Complaint that states that Local 331 paid 

for any Intron Franchise Drugs other than two Rebetol 

prescriptions. (See Local 331 Br. at 15, citing ¶¶ 19, 20, 21, 

117, 127, 128). 
22

of—the injury has to be fairly traceable to the challenged 

action of the defendant, and not the result of the independent 

action of some third party not before the court.‖ Lujan, 504 

U.S. at 560. In other words, the Amended Complaint must 

allege facts that plausibly support a causal connection 

between Local 331‘s injury-in-fact and Schering‘s allegedly 

illegal marketing or bribery schemes.

In arguing that the TPP Complaint meets this burden, 

Local 331 essentially repeats the reasoning that the District 

Court rejected. Specifically, it states that the TPP Complaint 

alleges both ―an overwhelming and reprehensible pattern of 

deceit by the defendants,‖ including false marketing and 

illegal inducements to doctors, and that this scheme was 

aimed at the TPPs. (Local 331 Br. at 18-19.) Local 331 

refers to allegations that Schering ―falsely marketed the 

Intron Franchise Drugs as efficacious‖ for off-label uses, but 

cites only to paragraphs that discuss Intron-A. (See TPP 

Compl. ¶¶178, 181, 182.) Likewise, Local 331 argues that 

Schering paid doctors to prescribe the drugs to patients who 

did not need them, but cites only to paragraphs referring to 

Intron-A, Temodar, or Rebetron. (See TPP Compl. ¶¶15-16, 

18, 36, 317-60, 278-89); (Local 331 Br. at 19). Local 331 

apparently believes that these allegations are an adequate 

basis to conclude that, but-for Schering‘s illegal conduct that 

increased off-sale prescriptions, ―Local 331 either would not 

have had to pay for them, or would not have had to pay for 

them at increased prices over readily-available therapies.‖ (Id.

at 19.) 

Local 331‘s suggestion that the claims about the other 

drugs are what caused the doctors to prescribe Rebetol for 

off-label uses is inadequate to establish causation. Local 331 
23

claims that the allegations about the other Subject Drugs, 

paired with the fact that ―Schering alone marketed Rebetol,‖ 

together reasonably support the inference that ―discovery will 

almost certainly confirm‖ that Schering also made ―false 

statements about all the drugs described in the Complaint.‖ 

(Local 331 Reply at 11.) Local 331 must allege facts 

sufficient to show that the Rebetol which it paid for was 

prescribed to its members for ineffective off-label uses 

because of Schering‘s alleged misconduct. There are no 

averments that come close to satisfying this standard. It is 

pure conjecture to conclude that because Schering‘s 

misconduct caused other doctors to write prescriptions for 

ineffective off-label uses for other products, Local 331 ended 

up paying for two prescriptions for Rebetol due to the same 

kind of misconduct. Accordingly, Local 331 has failed to 

show the requisite causal relationship between the alleged 

misconduct and its alleged injury. Therefore, dismissal for 

lack of standing is warranted.5

B. Montgomery

Montgomery, a consumer of Rebetol and PEG-Intron, 

brought the MAC on behalf of a putative nationwide class of 

consumers of the Subject Drugs. The MAC alleges facts 

 

5

The District Court also held that the failure to allege 

an injury-in-fact traceable to the alleged misconduct 

compelled the conclusion that the TPP Plaintiffs lacked 

standing to assert the common law tort claims of interference 

with contractual relations and unjust enrichment. We concur. 

Accordingly, there is no need to address the question of 

whether Local 331 alleged viable claims for interference with 

contractual relations or unjust enrichment. 
24

particular to her experience and use of two of the Subject 

Drugs, as well as the various legal theories pursued on behalf 

of the consumer plaintiffs.

Montgomery suffered from Hepatitis C, a viral liver 

infection, and after tests conducted in 1999 showed that she 

was asymptomatic, her physician, Dr. Jeffrey R. Willis, 

decided not to prescribe her a combination therapy of Rebetol 

and Intron-A. At a follow-up visit in September 2001, Dr. 

Willis recommended a different treatment plan,6even though 

Montgomery was still asymptomatic. A few months after this 

consultation, Dr. Willis prescribed Montgomery the PEGIntron and Rebetol combination therapy, also called the 

―PEG-Intron Combination Therapy.‖ (MAC ¶75.) 

The MAC avers that at the time she was prescribed the 

Subject Drugs, they were only approved for patients with 

 

6

The District Court observed an apparent 

inconsistency in the MAC regarding which drugs Dr. Willis 

decided not to prescribe in 1999—Intron-A and Rebetol, 

according to introductory parts of the MAC—and the drugs 

he decided to prescribe in 2001—Rebetol and PEG-Intron. 

(MAC ¶23.) The Court drew the ―reasonable inference that 

the treatment discussed in 1999 involved Rebetol and/or 

Intron-A, but not PEG-Intron‖ based on other information in 

the MAC. It also stated: ―despite the [MAC‘s] assertion that 

the  ̳same drugs‘ that Dr. Willis had rejected as unsuited to 

Montgomery‘s condition in 1999 were under consideration in 

2001, the records attached to the [MAC] and specifically 

referenced in paragraph 29 state that Dr. Willis recommended 

in 2001 that Montgomery receive . . . PEG-Intron, not Intron 

A.‖ (A. 109-110.)
25

compensated liver disease, and that since she was healthy and 

did not need treatment, she suffered from the serious side 

effects of the drugs and lost weeks of work due to these side 

effects. The MAC further claims that Dr. Willis changed his 

mind about her treatment plan because of Schering‘s 

improper marketing of the Rebetol/PEG-Intron combination 

therapy. Specifically, it alleges: ―Dr. Willis‘ new plan for 

Mrs. Montgomery‘s treatment for her asymptomatic Hepatitis 

C evidences that he was subjected to the marketing and sales 

scheme by Schering alleged in this Amended Complaint.‖ 

(MAC ¶30.)

The MAC reaches this conclusion based on the alleged 

facts that: (1) due to Schering‘s off-label marketing 

techniques, Dr. Willis mistakenly believed that the 

combination therapy was the standard treatment for 

Montgomery‘s condition; (2) Dr. Willis prescribed the 

combination therapy before sending Montgomery for two 

tests that he suggested were necessary before beginning the 

treatment; (3) Dr. Willis received misinformation from a 

nurse on his staff who was believed to be a Schering-paid 

nurse.

The MAC contains extensive factual allegations 

regarding the types of improper marketing techniques that 

Schering used, which Montgomery alleges must have 

influenced Dr. Willis between 1999, when he declined to 

prescribe her the drugs, and 2001, when he changed his 

treatment plan. The MAC reasserts many of the same 

allegations about Schering‘s techniques alleged in the TPP 

Complaint. The MAC also incorporates by reference all of 

the factual allegations made in a Qui Tam action brought 

against Schering in the District of Massachusetts, and the 
26

allegations in the Criminal Information, discussed above, to 

which Schering pleaded guilty. (MAC ¶¶ 99-101.) The 

allegations include claims about Schering‘s scheme for 

providing kickbacks to doctors for prescribing the drugs, false 

promotional claims made by sales representatives, and the 

placement of a Schering-paid nurse on Dr. Willis‘ staff. The 

MAC further alleges that Montgomery ―would not have been 

prescribed and would not have paid for such a costly, 

noxious, and dangerous medication cocktail had she known 

all the facts that were concealed by Defendants and her 

doctors . . . .‖ (MAC ¶¶ 4, 5.) 

The Defendants moved to dismiss the MAC under 

Rule 12(b)(1). The District Court dismissed the MAC for 

lack of jurisdiction under Rule 12(b)(1), finding that it failed 

to establish a sufficient nexus between her alleged injury and 

Schering‘s alleged misconduct. 

In reaching this conclusion, the Court first found that 

Montgomery had alleged an adequate injury-in-fact for her 

claims under the Washington Consumer Protection Act and 

various common law theories. The District Court held, 

however, that her ―standing to bring suit founders on her 

inability to establish any nexus between her purported 

injury—be it the needless purchase of the Rebetol/PEGIntron, the side-effects she claims to have suffered and/or the 

lost work time—and the wrongful conduct in which Schering 

was allegedly engaged.‖ (A. 117.) Montgomery‘s theory that 

the Defendants injured her is premised on whether Dr. Willis 

shifted his opinion about the appropriate treatment plan due to 

Schering‘s marketing practices. The District Court found that 

the MAC ―fails to provide any factual allegations that would 

support [this] conclusion.‖ (A. 118.) 
27

On appeal, Montgomery challenges the Court‘s 

dismissal of the MAC on several grounds. She argues that 

the Court improperly failed to consider certain factual 

allegations, some of which she claims establish the necessary 

causal link. Moreover, with respect to the factual allegations 

that the Court did consider, Montgomery argues that it 

applied an improper standard in rejecting those allegations as 

inadequate, and claims that when reviewed under the proper 

standard, they do adequately allege a causal nexus. 

Montgomery first challenges the District Court‘s 

decision on the ground that it erred in not fully considering 

―the entirety of the record‖ and taking all factual allegations 

as true. Montgomery notes that the MAC ―incorporates 

several other documents that set forth in great detail—beyond 

the extraordinary detail contained in the complaint itself—the 

nature and extent of Schering‘s alleged unfair deceptive acts 

and practices.‖ (Montgomery Br. at 25.) These documents 

include: (1) factual averments based on the personal 

knowledge of three former Schering employees in their 

related qui tam case filed in the District of Massachusetts 

(incorporated in the MAC at ¶105); (2) factual allegations 

about the Subject Drugs detailed in the related TPP Amended 

Complaint (incorporated in the MAC at n 1, A. 987); (3) the 

Criminal Information to which Schering pleaded guilty 

(incorporated in the MAC at ¶101); (4) the factual averments 

in the Settlement Agreement in the criminal case 

(incorporated in the MAC at ¶102); and (5) the Corporate 

Integrity Agreement and addendum to the same in the 

criminal case (incorporated in the MAC at ¶103). 

(Montgomery Br. at 25-26.) Montgomery asserts that ―it is 

not clear from the district court‘s opinion that it took proper 
28

account of these documents, and the substantial facts 

contained therein, in its ruling.‖ (Id. at 26.) 

In regard to these documents, the District Court stated:

Plaintiff apparently believes that somehow, 

through the incorporation of allegations made in 

other proceedings, such as the False Claims Act 

action filed by three qui tam relators, she can 

pursue her own relief against Schering. The 

irreducible minimum of Article III standing, 

however, requires Montgomery to demonstrate 

that she, personally, has suffered a concrete 

injury, that her injury can be traced to 

Schering‘s misconduct and that it is capable of 

redress by the Court. 

(A. 120.) This statement suggests that the District Court did 

not permit Montgomery to rely on factual allegations that 

pertain to the standing of other parties in order to establish her 

own standing. The Court also stated that it did not ignore 

those documents: ―Assuming Schering engaged in all of the 

marketing practices detailed in [the MAC] and in documents 

incorporated by reference, and assuming that the practices 

might be deemed unlawful, none of the factual allegations she 

makes establish the required nexus between her injury and 

Schering‘s actions.‖ (A. 120-21.) 

It is thus clear that the District Court did not ignore the 

documents that Montgomery sought to incorporate by 

reference in her Amended Complaint. It is also clear that the 

District Court properly concluded that the averments of 

misconduct did not support a non-conjectural conclusion that 

Dr. Willis had been induced by such misconduct to order the 
29

PEG-Intron Combination Therapy. Moreover, as a general 

matter, even if the Court did decline to consider some of these 

documents, this was not necessarily an error. Under Fed. R. 

Civ. P. 8(a)(2), a complaint should set forth a ―short and plain 

statement‖ of the claim to relief. Plaintiffs cannot be 

permitted to incorporate an endless series of external 

documents into a complaint simply ―by reference‖ to them, as 

this would lead to an impossible task for defendants in filing 

their answers, and for courts in reviewing the sufficiency of 

complaints. In any event, to the extent that Montgomery 

specifically claims that this alleged failure to consider 

particular allegations in the incorporated documents has 

prejudiced her—that is, that such allegations would have 

cured any of the deficiencies in stating causation—we discuss 

those arguments infra.

To establish standing, the MAC sought to allege a 

causal nexus between Dr. Willis‘ decision to prescribe the 

drugs to Montgomery, and the Defendants‘ alleged fraudulent 

marketing and bribery schemes. The District Court held that 

the MAC failed to adequately allege any connection between 

Schering‘s alleged bribery scheme and Montgomery‘s 

experience. The Court explained that the MAC ―lacks any 

allegation either directly accusing or even plausibly 

suggesting that . . . Dr. Willis received [illegal] 

remunerations.‖ (A. 120.) The Court also rejected the 

MAC‘s allegation about Dr. Willis‘s involvement in a clinical 

trial: 

In the case of Mrs. Montgomery and other 

asymptomatic Hepatitis C patients at [Dr. 

Willis‘ practice], upon information and belief 

based upon the evidence of record, it is alleged 
30

that Defendants engaged Dr. Willis in a phony 

clinical trial respecting Rebetron Combination 

Therapy beginning shortly after the August 

2001 FDA approval letter issued.

(MAC ¶93.)

The Court found this allegation inadequate because it 

was ―conclusory.‖ (A. 120.) Even ―assum[ing] the truth of 

fact asserted,‖ and ―credit[ing] the allegation that Dr. Willis 

was involved in a clinical trial,‖ the Court refused to ―credit 

the bald assertion that the trial was  ̳phony,‘ presumably 

meaning that Dr. Willis was not actually gathering data and 

studying patients. . . but [was only a] subterfuge for collecting 

payments from Schering for prescribing the drugs being 

studied.‖ (A. 120.) It rejected this assertion because 

―[n]othing in the [MAC] supports this characterization.‖ (A. 

120.) 

On appeal, Montgomery argues that the Court wrongly 

refused to accept this allegation as true. In our view, even if 

we found these arguments to be meritorious, they are still 

unavailing. Even if we accepted the MAC‘s allegation that 

Dr. Willis was involved in a ―phony‖ clinical trial for 

Rebetron Combination Therapy, this fact does not establish 

the necessary causal connection between Schering‘s 

misconduct and Montgomery‘s injury, because she was not 

prescribed the Rebetron Combination Therapy. To the 

contrary, she was prescribed the PEG-Intron Combination 

Therapy, a combination of Rebetol and another longer-lasting 

form of interferon, PEG-Intron. (See MAC ¶¶23, 64-66, 74.) 

Thus, as Schering observes: ―Dr. Willis‘s thoughts or 

clinical experiences with that drug therapy are of no moment 
31

here.‖ (Schering Br. at 26.) Notably, Montgomery does not 

apparently challenge this contention in her Reply Brief. In 

our view, the fact that the allegedly ―phony‖ trial did not even 

concern a treatment regimen that her doctor prescribed to her 

is dispositive. There is no allegation of fact that supports a 

connection between Schering‘s unlawful conduct of involving 

Dr. Willis in a ―phony‖ trial, and Montgomery‘s prescription 

for a different drug therapy. 

Montgomery‘s other arguments are equally 

unpersuasive. She contends that the Court ―unfairly 

rebuke[d] [her] for not  ̳directly accusing her doctor of a 

crime—i.e., engaging in a phony clinical trial—and 

defrauding his patients and the government.‖ (Montgomery 

Br. at 27.) She also invokes Rule 11 to argue that her lawyers 

were not permitted to make such an allegation about Dr. 

Willis at this time. (Id. at 28.) She continues: ―[t]he 

fundamental problem with the district court‘s dismissal is that 

the court required some direct accusation of criminal conduct 

by a non-party at the pleading stage. It was wrong to do so.‖ 

(Id.) 

This argument misconstrues the District Court‘s 

analysis, which did not require the MAC to charge Dr. Willis 

with a crime. Rather, the Court considered the allegation that 

the trial was ―phony‖ to be conclusory because there was 

simply no other allegation in the MAC to support the 

assertion that this particular trial was in fact a disguised 

bribery scheme. To satisfy the standard, the MAC would not 

have to allege that Dr. Willis had committed a crime, but state 

factual allegations suggesting that the clinical trial was in fact 

somehow fraudulent or undertaken in bad faith.
32

Montgomery argues that the MAC contains allegations 

that support the claim that the trial was ―phony,‖ including an 

allegation citing to a memorandum from one of the qui tam 

relators, a Schering employee who stated that ―his job is 

secure‖ in part because he had ―over 50 [Hepatitis] trials 

underway.‖ (Montgomery Br. at 30, citing MAC ¶ 94-95.) 

This general assertion that 50 Hepatitis clinical trials were 

underway, however, does not support the conclusion that Dr. 

Willis‘s trial was one of those phony trials. These allegations 

therefore do not ―bolster the main allegation‖ that Dr. Willis 

was involved in a ―phony‖ clinical trial. (Id. at 30.)

Montgomery points to no other factual allegations in 

the MAC that support the conclusion that Dr. Willis was in 

any way connected with phony trials. The allegation 

therefore does appear to be a speculative conclusion that falls 

short of stating facts that raise a ―plausible‖ right to relief. 

We conclude that the Court did not err in rejecting the 

assertion, without other supporting factual claims, that Dr. 

Willis was involved in a phony clinical trial. See Morse v. 

Lower Merion Sch. Dist., 132 F.3d 902, 906 (3d Cir. 1997)

(holding that a court reviewing a complaint need not credit 

―bald assertions‖ or ―legal conclusions‖).

The MAC also claimed that three other Scheringsponsored programs associated with Montgomery‘s treatment 

under Dr. Willis were the causal link between his prescription 

and Schering‘s false marketing campaign. First, the MAC 

alleges that a Schering-paid nurse in Dr. Willis‘ office, 

identified in the MAC as ―D.S.‖ or ―Diana S.,‖ was part of 

the marketing scheme that affected her treatment. (MAC ¶

42-25.) The Court held that this allegation that Diana S. ―was 

part of Schering‘s deceitful marketing scheme and somehow 
33

caused Dr. Willis to prescribe Rebetol/PEG-Intron to 

Montgomery is purely conclusory.‖ (A. 119.) The Court 

reasoned that, at most, it could accept as true the alleged 

facts, which stated that this nurse was paid by Schering to 

provide patient support in matters concerning injectiontraining and side effects; however, the Court concluded, 

―there is no indication that Schering executed the alleged 

misrepresentations or kickbacks through this PCC.‖ (A. 119.) 

The MAC makes numerous allegations about ―Diana 

S.‖ based on ―information and belief‖; it never explains, 

however, the basis for its conclusion that she was in fact 

employed by Schering, or that she disseminated any false 

information to Dr. Willis about the Subject Drugs. In our 

view, the MAC fails to allege sufficient facts to ―show‖ that 

her treatment plan was influenced by Diana S. at the behest of 

Schering. 

The District Court also discredited the MAC‘s 

allegations with respect to two other Schering-sponsored 

programs, the ―Access Assurance Program‖ and ―Be in 

Charge Program.‖ According to the MAC, the ―Access 

Assurance Program‖ supported patients who were undergoing 

treatments by the Subject Drugs by ensuring they had a 

consistent supply of the product, and also allegedly to serve 

as a marketing technique. (MAC ¶ 48-51.) Similarly, the 

―Be in Charge‖ program was designed to help support 

patients on Rebetron therapy by providing them with a nurse 

to ensure ―such patients were  ̳compliant‘‖ with the therapy 

program, so that Schering could ―ensure that [it] sold as much 

Rebetron Combination Therapy as possible.‖ (MAC ¶ 52.) 

However, the MAC provides no factual allegations describing 

how either of these programs interfered with Dr. Willis‘ 
34

decision to prescribe Montgomery the Subject Drugs through 

any false information, or that it gave her any false claims 

about the drugs that otherwise injured her. Accordingly, we 

conclude that these allegations are not sufficient to form the 

necessary causal nexus.

Montgomery also raises a handful of other claims that 

are ultimately unavailing. She argues that the MAC properly 

pleaded causes of action for statutory consumer fraud, 

common law conspiracy, aiding and abetting and unjust 

enrichment. (Montgomery Br. at 45.) Montgomery argues 

that the Court should have evaluated her standing to bring the 

claims with regard to each particular claim, and notes that 

other than a brief discussion of the Washington Consumer 

Protection Act, the Court‘s opinion contains ―no discussion of 

the elements of the plaintiff‘s four claims, or the sufficiency 

of her allegations of the same in the MAC.‖ (Id. at 46.) She 

requests that we vacate the decision and remand it ―for failure 

to adequately address the first step of the requisite two-step 

process under Rule 12.‖ (Id., quoting Fowler, 578 F.3d at 210

(―First, the factual and legal elements of a claim should be 

separated.‖)). Montgomery then proceeds to exhaustively 

discuss how the MAC pleads all of the requisite elements of 

each of her claims.

Montgomery‘s focus on the pleading standards for 

each of her claims is secondary to the threshold issue that the 

Court addressed when determining that the MAC did not 

adequately allege an injury fairly traceable to Schering‘s 

alleged misconduct. Although the MAC is replete with 

factual allegations and indeed asserts them with greater 

specificity than the TPP Complaint, they do not present a 

plausible allegation actually linking Montgomery‘s injuries to 
35

any type of miscommunication or false claim about the drugs 

that were actually prescribed to her. Accordingly, we will 

affirm the Court‘s conclusion that the MAC failed to 

adequately allege causation.

IV.

Neither appellant – Local 331 nor Montgomery – has 

alleged facts sufficient to confer standing to seek relief for 

Schering‘s marketing of certain drugs for off-label uses. 

Accordingly, we will affirm the District Court‘s rulings.